COMPLIANCE POLICY GUIDE (CPG)
CPG Sec 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine (CPG 7108.24) November 2024
- Docket Number:
- FDA-2021-D-0367
- Issued by:
-
Guidance Issuing OfficeHuman Foods ProgramOffice of Inspections and Investigations
The purpose of this compliance policy guide (CPG) is to provide guidance for FDA staff on adulteration associated with decomposition and/or histamine identified during surveillance sampling and testing of fish and fishery products susceptible to histamine formation.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.
Download the Compliance Policy Guide (CPG)
Related Resources
- FDA Issues Final Compliance Policy Guide for Scombrotoxin (Histamine)-forming Fish and Fishery Products
- Seafood
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2021-D-0367.